Registration Dossier
Registration Dossier
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EC number: 444-010-7 | CAS number: 82654-98-6
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17.04.2007 - 02.05.2007
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial gene mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 444-010-7
- EC Name:
- -
- Cas Number:
- 82654-98-6
- Molecular formula:
- C12H18O3
- IUPAC Name:
- 4-(butoxymethyl)-2-methoxyphenol
Constituent 1
Method
- Target gene:
- Salmonella typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- Highest concentration for bacteriostatic control: 500 ug/plate; highest concentration for the two other controls and mutagenic assay: 700 ug/plate. Further concentrations: 210, 70, 21 and 7 ug/plate
- Vehicle / solvent:
- Yes, substance dissolved in DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- For S. Typhimurium TA 1535, TA 100 without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- For TFor S. Typhimurium TA 1537 without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- For S. Typhimurium TA 98 without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: cis-Platinium (II)
- Remarks:
- For E. Coli without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-anthramine
- Remarks:
- For S. Typhimurium TA 1535, TA 1537, TA 100 and TA 98 with metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9,10-dimethylbenzanthracene
- Remarks:
- For E. Coli with metabolic activation
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- At the highest concentration (700 ug/plate) has less than 75% cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
In the test conditions, in the presence of the test substance (700 ug, 210 ug, 70 ug, 21 ug and 7 ug/plate), the test substance does not induce any mutagenic change in Salmonella typhimurium TA 1535, TA 1537, TA99, TA100 and Escherichia coli WP2(uvrA) (pKM 101), without or with metabolic activation according to the OECD Guidelines n°471 and to the method B13/B14 of the directive 2000/32/EC
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